Lirafugratinib for adults with FGFR2-fusion or -rearranged non-cholangiocarcinoma solid tumors
A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement
This trial tests whether lirafugratinib can help adults with previously treated, unresectable or metastatic non-cholangiocarcinoma solid tumors that have an FGFR2 fusion or rearrangement.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elevar Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, lirafugratinib |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT07359820 on ClinicalTrials.gov |
What this trial studies
This is a phase 2, open-label interventional trial enrolling adults whose unresectable, locally advanced, or metastatic solid tumors (excluding cholangiocarcinoma) harbor FGFR2 fusion or rearrangement and who have received at least one prior systemic therapy. Participants receive oral lirafugratinib on a prescribed schedule and attend regular clinic visits for safety labs, imaging, and other assessments. Tumor response is measured by RECIST v1.1 and adverse events are monitored throughout treatment. Patients with prior FGFR inhibitor exposure are excluded and eligibility requires ECOG performance status 0–1 and adequate organ function.
Who should consider this trial
Good fit: Adults with unresectable, locally advanced, or metastatic non-cholangiocarcinoma solid tumors with documented FGFR2 fusion or rearrangement, measurable disease by RECIST v1.1, ECOG 0–1, adequate organ function, at least one prior systemic therapy, and no prior FGFR inhibitor exposure are ideal candidates.
Not a fit: Patients without an FGFR2 fusion/rearrangement, those with poor organ function, uncontrolled comorbidities, active uncontrolled infections as defined by the protocol, prior FGFR inhibitor treatment, or a diagnosis of cholangiocarcinoma are unlikely to benefit from this trial.
Why it matters
Potential benefit: If lirafugratinib works, it could shrink tumors or slow disease progression in patients with FGFR2-fusion or -rearranged non-cholangiocarcinoma solid tumors who have limited treatment options.
How similar studies have performed: Other FGFR-targeting drugs have produced meaningful responses in FGFR2-fusion cancers—most notably in cholangiocarcinoma—supporting the targeted approach though evidence outside cholangiocarcinoma is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unresectable, locally advanced, or metastatic solid tumor (other than CCA). * Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor. * Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1. * Previously (\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies. * Subject has not received prior treatment with an FGFRi. Exclusion Criteria: * An uncontrolled comorbidity. * Patient does not have adequate organ function (defined in protocol). * Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol). * QT interval corrected using Fridericia's formula (QTcF) \> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome. * Clinically significant, uncontrolled cardiovascular disease. * CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.
Where this trial is running
Phoenix, Arizona and 18 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Not_yet_recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Not_yet_recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Institut Bergonie — Bordeaux, France (Not_yet_recruiting)
- Centre Georges François Leclerc — Dijon, France (Not_yet_recruiting)
- Centre Leon Berard — Lyon, France (Not_yet_recruiting)
- Gustave Roussy Cancer Campus — Paris, France (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- START Barcelona-Hospital HM Nou Delfos — Barcelona, Spain (Not_yet_recruiting)
- Hospital Universitario Fundación Jiménez Díaz- START MADRID — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario HM Sanchinarro-START MADRID-CIOCC — Madrid, Spain (Not_yet_recruiting)
- University College Hospital (NIHR UCLH Clinical Research Facility) — London, United Kingdom (Not_yet_recruiting)
- Sarah Cannon Research Institute UK — London, United Kingdom (Not_yet_recruiting)
- The Christie NHS Foundation — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Jacki Dillingham
- Email: jdillingham@elevartx.com
- Phone: +1 (385) 276-3611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.